WELCH ALLYN PREMIUM LIGHTWEIGHT HEADLIGHT
FDA 510(k) clearance K952691 · decided 1995-07-31
Clearance details
- K-number
- K952691
- Device name
- WELCH ALLYN PREMIUM LIGHTWEIGHT HEADLIGHT
- Applicant
- Welch Allyn, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-06-12
- Decision date
- 1995-07-31
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- FJC
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Skaneateles Falls, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.